What side effects are associated with this type of intervention?

Common treatments for Neurotrophic Keratitis include topical drops (artificial tears, antibiotics, steroids), bandage contact lenses, and punctal plugs. Side effects of these treatments can vary: artificial tears generally have minimal side effects but can sometimes cause temporary blurred vision or mild irritation. Topical antibiotics may lead to allergic reactions or resistance with prolonged use. Steroids can cause increased intraocular pressure, cataract formation, and potential worsening of infections. Bandage contact lenses might result in discomfort, infection, or corneal hypoxia. Punctal plugs are generally safe but can occasionally cause irritation or infection at the insertion site.

What prior FDA approvals exist?

The FDA has approved cenegermin (Oxervate) for the treatment of neurotrophic keratitis. Cenegermin is a recombinant human nerve growth factor that promotes epithelial cell growth and wound healing, similar to the mechanism being studied for topical insulin. This treatment has shown prolonged effects in improving corneal sensation and healing persistent epithelial defects associated with neurotrophic keratopathy.

What other types of research exist?

Promising novel alternatives to topical insulin for neurotrophic keratitis include: <ol> <li>Topical Nerve Growth Factor (NGF): Cenegermin, an NGF, has been approved for neurotrophic keratitis and promotes corneal healing by stimulating nerve regeneration and epithelial cell growth.</li> <li>Amniotic Membrane Transplantation: This involves the use of amniotic membrane grafts to promote healing and reduce inflammation in the cornea.</li> <li>Recombinant Human Nerve Growth Factor (rhNGF): Similar to cenegermin, rhNGF is under investigation for its potential to enhance corneal nerve regeneration and epithelial healing.</li> <li>Serum Eye Drops: Autologous serum eye drops contain growth factors and vitamins that support corneal healing and have been used for various ocular surface disorders, including neurotrophic keratitis.</li> </ol>

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Hormone Therapy

Topical Insulin Drops for Neurotrophic Keratitis

Phase 2 & 3

Waitlist Available

Led By Christopher J Rudnisky, MD MPH

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests insulin eye drops to heal eye surface damage in patients with neurotrophic keratitis who haven't improved with standard treatments. Insulin helps eye cells repair themselves, potentially speeding up healing. Low dose insulin eyedrops have been shown to be a simple and effective treatment for neurotrophic keratopathy when the response to the usual treatment is incomplete.

Who is the study for?

This trial is for adults over 18 with neurotrophic keratitis, a condition where the cornea loses sensation and doesn't heal properly. Participants must have tried other treatments without success and be able to consent to using topical insulin drops.

What is being tested?

The study tests if topical insulin can help heal the cornea in patients with neurotrophic keratopathy who haven't responded to standard care. It compares this new approach against more invasive procedures like tarsorrhaphy (partially sewing eyelids together).

What are the potential side effects?

Topical insulin might cause eye irritation, discomfort, or allergic reactions. Tarsorrhaphy may lead to altered eyelid appearance, infection at the stitch site, or difficulty fully closing the eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to re-epithelialization of neurotrophic ulcer

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Topical insulinExperimental Treatment1 Intervention

Topical insulin (Humulin R) will be compounded under sterile conditions at a local pharmacy at a concentration of 25 IU / ml in sterile balanced saline solution (0.9%). Topical insulin will be administered four times per day to the affected eye. A bottle of topical insulin can be used for 14 days. Any remaining topical insulin will be discarded as waste after 14 days.

Group II: TarsorrhaphyActive Control1 Intervention

Patients in this group will receive a temporary, central tarsorrhaphy and will not use additional eye drops.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin

2000

Completed Phase 4

~4280

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neurotrophic Keratitis treatments aim to promote corneal healing and restore nerve function. Topical insulin, as studied, promotes epithelial cell growth and wound healing, which is crucial for repairing the damaged corneal surface. Other treatments include nerve growth factor (NGF) eye drops, which enhance corneal innervation and epithelial healing by increasing NGF receptors and stem cell markers. These treatments are vital for Neurotrophic Keratitis patients as they address the underlying issue of impaired corneal sensation and healing, reducing the risk of persistent epithelial defects, recurrent erosions, and corneal ulcers.

Specificity of a neuronotrophic factor from rabbit corneal epithelial cultures.Corneal Epithelium-Derived Neurotrophic Factors Promote Nerve Regeneration.Capsaicin-induced corneal sensory denervation and healing impairment are reversed by NGF treatment.